Hybrid Energy (HE) disposable tips 30010080

GUDID 07290016586060

POLLOGEN LTD

Radio-frequency skin contouring system applicator tip
Primary Device ID07290016586060
NIH Device Record Keya5c6e5d1-dad6-4a97-ab84-e79ac152a85c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHybrid Energy (HE) disposable tips
Version Model Numbergen12
Catalog Number30010080
Company DUNS514905681
Company NamePOLLOGEN LTD
Device Count5
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016586060 [Primary]
GS117290016586067 [Unit of Use]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-06

On-Brand Devices [Hybrid Energy (HE) disposable tips]

07290016586060gen12
07290016586053gen36
07290016586275Hybrid Energy (HE) disposable tips gen36L
07290016586268Hybrid Energy (HE) disposable tips gen100

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